BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1494005 · Received August 24, 2009

    Report

    Report Number
    9710014-2009-00313
    Event Type
    Malfunction
    Date Received
    August 24, 2009
    Date of Event
    August 1, 2009
    Report Date
    August 18, 2009
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS FROM (B) (6) AND IS CURRENTLY VISITING NEW YORK ON VACATION. SHE HAD A SUDDEN LOSS OF SOUND FROM HER DEVICE. SHE WAS IMMEDIATELY SEEN AT A CLINIC IN (B) (6) ON (B) (6) 2009. THE EXTERNAL EQUIPMENT WAS EXAMINED AND FOUND TO BE IN GOOD WORKING ORDER. THE CLINIC USED BACK-UP EQUIPMENT AND WERE ABLE TO DOWNLOAD HER PROGRAMS, BUT SHE WAS STILL UNABLE TO HEAR. TESTING WAS CARRIED OUT AND SHOWED THAT THE DEVICE HAS MALFUNCTIONED. MED-EL CORP CARRIED OUT FURTHER TESTING ON (B) (6) AND CONFIRMED THAT THE DEVICE HAS MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH C40+

    Patients

    Seq Age Sex Outcome Treatment
    1